At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 12 enrolled
Drug / intervention
ertapenem +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers
In Brief
A Phase 4 clinical trial evaluating ertapenem for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartAug 2010
Primary CompletionOct 2010
TodayJul 2026
First PostedJun 22, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.0 years ago
Interventions
ertapenemdrug
1 gram IV bolus every 24 hours (q24h) for 3 days
ertapenemdrug
1 gram 30 minute infusion q24h for 3 days